Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis. On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrolment of first patients in an international clinical phase-III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (eg Alzheimer’s disease [AD]). In the previous phase-II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients.
“Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease,” said Dr Thomas Balzer, head of Global Clinical Development Diagnostic Imaging at Bayer Schering Pharma. “This phase-III study could proof that florbetaben can be used as a new tool to detect beta-Amyloid depositions in the brain in vivo. The ability to image beta-Amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment.”
Florbetaben is an inlicensed 18F-labelled PET tracer that specifically binds to deposition of beta-Amyloid.